In general our programs fall under ANSI N323, but in this case it's what the vendor QA program prescribes. IEC 17025 is an international QA doc for testing and cal labs. I think those provisions would apply to their lab instruments and not the GM frisker they may be calibrating for you. That's lab QA, not inst cals like ANSI N323. In the end it's what the vendor describes in their QA program and as long as they give us something that will meet ANSI N323 we will be happy.
The application of standards can sometimes be an issue. You might have a vendor that performs multiple services with some that might fall under 10CFR50 and some lesser services that might fall under a lesser ANSI std. Before we approve vendors, we approve them and their QA program is a part of that process. Once they are an approved vendor, we audit them to their QA program. We periodically provide feedback to vendors about their QA programs and how they can provide their service in the most efficient manner. I haven't read their QA program, but we only need ANSI N323 which would not require a tamper seal on instruments. Glen Vickers, CHP Exelon Corp RP Technical Lead 815-216-2723 (work/cell) From: Powernet <[email protected]> On Behalf Of Tom Meek via Powernet Sent: Tuesday, April 9, 2019 2:25 PM To: [email protected] Cc: Tom Meek <[email protected]>; 'Mark Tursa' <[email protected]>; Jim VanLooven <[email protected]> Subject: [EXTERNAL] [Powernet] RP field instrument tamper seals I have a question regarding tamper resistant seals for calibration on RP meters. A QA audit made a SFR (supplier finding report) at an instrument calibration facility stating vendor should be placing these seals on our RP meters. The cited standard is ANSI Z540:1994 Section 11.5, but after some discussion we agreed that this only applies to lab standards. He also cited ISO 17025:2017 Section 6.4.12 which states "the laboratory shall take practical measures to prevent unintended adjustments of equipment from invalidating results." The auditor said that industry interprets this as requiring tamper seals, but also said that complying with the ISO standard was a matter of lab certification only (not a regulatory requirement). Does any site require tamper resistant seals on RP field instruments? Yes No If yes how do you handle routine battery and/or desiccant replacement? What do you do if a seal is found broken or missing. In short, would the event be entered into the corrective action system? Do you rely on your source check and zero check of the instrument to "validate" its calibration in lieu of the tamper seal? Thanks in advance Tom Meek, CHP This Email message and any attachment may contain information that is proprietary, legally privileged, confidential and/or subject to copyright belonging to Exelon Corporation or its affiliates ("Exelon"). This Email is intended solely for the use of the person(s) to which it is addressed. If you are not an intended recipient, or the employee or agent responsible for delivery of this Email to the intended recipient(s), you are hereby notified that any dissemination, distribution or copying of this Email is strictly prohibited. If you have received this message in error, please immediately notify the sender and permanently delete this Email and any copies. Exelon policies expressly prohibit employees from making defamatory or offensive statements and infringing any copyright or any other legal right by Email communication. Exelon will not accept any liability in respect of such communications. -EXCIP
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